Cognition Therapeutics, Inc. (NASDAQ: CGTX), a
clinical-stage neuroscience company developing drugs that treat
age-related degenerative disorders by regulating cellular damage
response pathways, today announced topline results from its Phase 2
double-blind, single-crossover SEQUEL study (NCT04735536) of CT1812
in 16 adults with mild-to-moderate Alzheimer’s disease. The study,
which was conducted in the Netherlands, met its primary endpoints
for safety and tolerability and showed positive effects for
CT1812-treated participants as measured via quantitative
electroencephalogram (qEEG).
Research suggests that overall slowing of brain activity in
Alzheimer's disease can be measured by an increase in relative
theta power using qEEG and other measures of brain connectivity.
The SEQUEL study examined brain wave changes over 4 weeks of
treatment and showed that participants treated with CT1812
experienced a numerical reduction in relative theta power compared
to the period when they were on placebo. While not statistically
significant, these data indicate a positive impact on underlying
brain function and are supported by nominally significant and
directionally positive changes in AECc and alpha power.
In addition to global measures of brain activity, this study
assessed brainwave changes in frontal, central, temporal and
posterior (occipital and parietal) regions. Treatment with CT1812
was associated with decreases in relative theta in each of
these regions, with statistical significance in the change in
relative theta in the central region.
“My colleagues and I are excited to see this favorable result,
which suggests that treatment with CT1812 may be directly impacting
overall brain health, as illustrated in a change in relative theta
power globally and across brain regions,” said Everard (Jort)
Vijverberg, M.D., Ph.D., a neurologist and senior researcher at the
Amsterdam University Medical Centers, and principal investigator in
SEQUEL. “We look forward to continuing our work with Cognition as a
clinical trial collaborator in the SHINE study, which is studying
CT1812 over a six-month treatment period in 144 adults with
mild-to-moderate Alzheimer’s disease.”
In addition to changes in theta wave patterns, an AECc analysis
of the qEEG results showed that CT1812 treatment was associated
with nominally statistically significantly greater
connectivity between brain regions. The brain’s ability to
communicate and exchange information between regions is critical to
cognition.
“While the study of brain connectivity is evolving, many
consider this to be a highly relevant measure, as it demonstrates
how well a brain network is functioning,” added explained Willem de
Haan, M.D. Ph.D., a neurologist and senior researcher at the
Amsterdam University Medical Centers’ Alzheimer Center. “The
positive insights derived from this study could encourage other
researchers and industry members to use qEEG as a measurement tool
during clinical trials, as well as healthcare professionals
monitoring disease progression and during the delivery of
care."
As observed in previous studies, CT1812 was well-tolerated in
the SEQUEL study with most adverse events being mild-to-moderate in
severity. There were no treatment-related SAEs reported.
The SEQUEL study, which was supported by a grant from the
National Institute on Aging (R01AG058710), was designed to assess
differences in synaptic function in CT1812-treated versus
placebo-treated participants using qEEG to measure changes in brain
wave patterns. The sophisticated algorithms used by qEEG allow
small changes in brain activity to be quantified. The changes in
amplitude and frequency of wavebands over time can provide insight
into the levels of activity in and between brain regions. As a fast
and cost-effective method of measuring the electrical activity of
the brain, qEEG may represent a non-invasive biomarker of
Alzheimer's disease progression and treatment effect.
“Though an exploratory endpoint, there is substantial evidence
to believe that qEEG can detect changes in both whole-brain and
regional electrical patterns that are impaired in Alzheimer’s
disease,” said Anthony Caggiano, M.D., Ph.D., Cognition’s chief
medical officer and head of R&D. “These results show CT1812’s
impact on neurophysiological endpoints, which add to the growing
body of evidence that we have compiled in our preclinical and
clinical programs: CT1812’s target engagement observed in the SNAP
study, its impact on anatomical endpoints observed in the SPARC
study, and preliminary cognitive impact seen in the first cohort of
patients in the SHINE study.”
Lisa Ricciardi, CEO of Cognition Therapeutics, added, “Each of
our specialty pharmacology studies and our extensive biomarker
analyses have supported the findings from our preclinical studies
and provided us with important insights into the role of the σ-2
receptor and the potential impact of treatment with CT1812. We are
increasingly optimistic about the larger patient studies that are
underway in Alzheimer’s disease, as well as in dementia with Lewy
bodies and dry age-related macular degeneration where we think the
protective cellular role may further benefit patients.”
Ms. Ricciardi concluded, “We feel fortunate to announce positive
findings from SEQUEL during this period when the community is
commemorating Alzheimer’s & Brain Awareness Month. During June
in particular we recognize the challenges of Alzheimer’s and other
dementias that affect more than 55 million people worldwide. It
gives us the opportunity to reflect and recommit to our mission to
bring effective treatment to those suffering from these devastating
diseases.”
Full analyses of the results from SEQUEL will be presented at an
upcoming medical meeting, as will analyses of Alzheimer's canonical
biomarkers and proteomics from fluid samples collected from SEQUEL
participants.
Webcast and Conference CallCognition will host
a conference call and webcast on June 28, 2023, at 8:00am ET to
discuss these topline results. The call can be accessed by dialing
(800) 715-9871 for U.S. Callers and (646) 307-1963 for
international callers five minutes prior to the start of the call
and providing the conference ID 7557195. A live webcast will be
available on the company's website at www.cogrx.com/events and
will be archived for 90 days.
About CT1812CT1812 is an experimental orally
delivered small molecule designed to penetrate the blood-brain
barrier and bind selectively to the sigma-2 (σ-2) receptor complex.
The σ-2 receptor complex is involved in the regulation of key
cellular processes such as membrane trafficking and autophagy that
are damaged by toxic interaction with soluble beta amyloid (Aβ)
oligomers, oxidative stress and other stressors. This damage to
sensitive synapses can progress to a loss of synaptic function,
which manifests as cognitive impairment and Alzheimer’s disease
progression. CT1812 is currently in development for
mild-to-moderate Alzheimer’s disease in the SHINE study
(NCT03507790) and dementia with Lewy bodies in the SHIMMER study
(NCT05225415).
About Cognition Therapeutics, Inc.Cognition
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
engaged in the discovery and development of innovative, small
molecule therapeutics targeting age-related degenerative disorders
of the central nervous system and retina. We are currently
investigating our lead candidate CT1812 in clinical programs in
Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry
age-related macular degeneration (dry AMD). We believe CT1812 and
our pipeline of investigational σ-2 receptor modulators can
regulate pathways that are impaired in these diseases. We believe
that targeting the σ-2 receptor with CT1812 represents a mechanism
functionally distinct from other current approaches in clinical
development for the treatment of degenerative diseases. More about
Cognition Therapeutics and its pipeline can be found at
http://cogrx.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release, other than statements of
historical facts or statements that relate to present facts or
current conditions, including but not limited to, statements
regarding our product candidates, including CT1812, and any
expected or implied benefits or results, including that initial
clinical results observed with respect to CT1812 will be replicated
in later trials and our clinical development plans, are
forward-looking statements. These statements, including statements
relating to the timing and expected results of our clinical trials
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance, or
achievements to be materially different from any future results,
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subject to a number of risks, uncertainties and assumptions, some
of which cannot be predicted or quantified and some of which are
beyond our control. Factors that may cause actual results to differ
materially from current expectations include, but are not limited
to: competition; our ability to secure new (and retain existing)
grant funding; our ability to grow and manage growth, maintain
relationships with suppliers and retain our management and key
employees; our ability to successfully advance our current and
future product candidates through development activities,
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uncertainties inherent in the results of preliminary data,
pre-clinical studies and earlier-stage clinical trials being
predictive of the results of early or later-stage clinical trials;
the timing, scope and likelihood of regulatory filings and
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changes in applicable laws or regulations; the possibility that the
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estimates of expenses and profitability; the evolution of the
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initiatives and continue to innovate our existing products; our
ability to defend our intellectual property; the impact of the
COVID-19 pandemic on our business, supply chain and labor force;
and the risks and uncertainties described more fully in the “Risk
Factors” section of our annual and quarterly reports filed with
the Securities Exchange Commission and are available at
www.sec.gov. These risks are not exhaustive and we face both known
and unknown risks. You should not rely on these forward-looking
statements as predictions of future events. The events and
circumstances reflected in our forward-looking statements may not
be achieved or occur, and actual results could differ materially
from those projected in the forward-looking statements. Moreover,
we operate in a dynamic industry and economy. New risk factors and
uncertainties may emerge from time to time, and it is not possible
for management to predict all risk factors and uncertainties that
we may face. Except as required by applicable law, we do not plan
to publicly update or revise any forward-looking statements
contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
Contact Information:Cognition Therapeutics,
Inc.info@cogrx.com
Aline Sherwood (media)Scienta
Communicationsasherwood@scientapr.com
Daniel Kontoh-Boateng (investors) Tiberend Strategic Advisors,
Inc. dboateng@tiberend.com
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